WEBINARS

 

Medical Device R&D Regulatory Compliance Training - Live Webinars, Recordings & CDs

How to Prepare a Standard Operating Procedure (SOP)?

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705131

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.

Recording Available

* Per Attendee $299

 

Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 701898

This 90-minute webinar will examine in detail the U.S. FDA and EU MDD requirements for DHFs, DMRs, DHRs, and TF/DDs - their formats, content, and their commonalities, differences, interrelationships, and similarities.

Recording Available

* Per Attendee $249

 

Introduction to Root Cause Investigation for CAPA

webinar-speaker   Vanessa Lopez

webinar-time   60 Min

Product Id: 704409

This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.

Recording Available

* Per Attendee $299

 

Implementing a Bullet Proof Quality System for FDA Audit Success

webinar-speaker   Meena Chettiar

webinar-time   60 Min

Product Id: 705400

This webinar will provide an overview of the FDA expectations in medical device industries for setting up a quality system for FDA audit readiness. It will also provide an understanding of the quality system inspection techniques (QSIT) requirements for documents controls, production and process controls, packaging and labeling controls and more.

Recording Available

 

Understanding Key Quality System Requirements for Combination Product (Medical device and Pharmaceuticals) Manufacturers

webinar-speaker   Meena Chettiar

webinar-time   60 Min

Product Id: 705401

This webinar will explain the quality system regulations (QSR) for combination device manufacturers to ensure compliance with for FDA and ISO 13485 requirements. It will also provide practical tips to sustain the growth of your quality system in the long run.

Recording Available

* Per Attendee $349

 

Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

webinar-speaker   Vanessa Lopez

webinar-time   90 Min

Product Id: 704758

This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.

Recording Available

* Per Attendee $299

 

Understanding FDA Design Verification and Validation Requirements for Medical Devices

webinar-speaker   Meena Chettiar

webinar-time   75 Min

Product Id: 705331

This webinar will help you understand specific product verification and validation requirements for medical devices to comply with ISO 13485: 2016 and FDA quality system regulations. It will focus on the topics such as product development process, traceability and risk management at all stages, design outputs and documentation in DMR and DHR, design verification and design validation activity cycles and more.

Recording Available

* Per Attendee $299

 

Sterilization of Pharmaceutical Products and Medical Devices

webinar-speaker   Carl Patterson

webinar-time   90 Min

Product Id: 705310

This webinar will discuss in detail the methods of sterilization to be used on medical devices and pharmaceutical products including advantages and disadvantages of each method. Also attendees will understand the regulations pertaining to sterilization of products that will help to decide with method to use for their product. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.

Recording Available

* Per Attendee $299

 

Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 705370

This webinar will focus on the key regulatory requirements for medical devices for the participating MDSAP countries of U.S., Canada, Brazil, Australia and Japan. It will address key topics such as device classification, licensing pathways, medical device GMP, inspections, device labeling, license holder responsibilities and more.

Recording Available

* Per Attendee $299

 

You have a BI Positive or Product Sterility Positive - Now What?

webinar-speaker   Gerry O Dell

webinar-time   60 Min

Product Id: 703288

This webinar will discuss what actions should be taken following a positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It will also explain the various items that should be investigated to determine the root cause and the follow up to the investigation.

Recording Available

* Per Attendee $299

 

Failure Mode Effects Analysis

webinar-speaker   Michael Abitz

webinar-time   60 Min

Product Id: 705333

This webinar will explain how to create Failure Mode Effects Analysis (FMEA) by combining Effective Information Collection (EIC), Process Reliability Modeling (PRM) and Failure Mode Effect Criticality Analysis (FMECA). It will also cover the methods for determining root causes of process problems and effective tools for repair of ineffective processes.

Recording Available

* Per Attendee $299

 

The New Usability Engineering Requirements of IEC 62366-1:2015, 2: 2016

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 705111

This webinar will focus on the IEC standard and its key requirements: “IEC 62366-1:2015 Part 1: Application of usability engineering to medical devices”. It will touch on “IEC/TR 62366-2:2 Part 2: Guidance on the application of usability engineering to medical devices”. Another webinar will focus on Part 2, and re-evaluate key portions of Part-1.

Recording Available

* Per Attendee $299

 

New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products

webinar-speaker   Angela Bazigos

webinar-time   90 Min

Product Id: 704529

This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.

Recording Available

* Per Attendee $249

 

Process Challenge Device Development for EO Sterilization

webinar-speaker   Gerry O Dell

webinar-time   90 Min

Product Id: 703443

This webinar will discuss the role of Process Challenge Devices (PCDs) both during ethylene oxide (EO) validation and during routine processing. It will explain the difference in requirements for PCD during both the processes.

Recording Available

* Per Attendee $299

 

Technical Writing for Medical Products: SOPs, Investigations and Change Records

webinar-speaker   Regina Fullin

webinar-time   60 Min

Product Id: 704304

In this training program, attendees will learn quick formatting tips that will make writing more readable and learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system.

Recording Available

* Per Attendee $299

 

Risk Analysis in Medical Device Design

webinar-speaker   Charles H Paul

webinar-time   60 Min

Product Id: 704803

This webinar will discuss the regulatory requirements and the processes, tools and techniques for conducting an effective risk and hazard analysis for medical devices as per FDA, FTA, FMEA, and FMECA guidelines.

Recording Available

 

FDA Regulations for Environmental Monitoring (EM) Program

webinar-speaker   Joy McElroy

webinar-time   90 Min

Product Id: 704377

This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.

Recording Available

* Per Attendee $299

 

Cell Based Assays: Development and Validation

webinar-speaker   Michael Simonian

webinar-time   60 Min

Product Id: 704528

This training program will focus on how cell cultures are used for in vitro assays. It will include examples of cell based assay systems and list the advantages of cell based assays. The webinar will help attendees understand the uses of in vitro testing with eukaryotic cell based systems, the parameters to be considered in the development and optimization of a cell based assay and the validation of a cell based assay.

Recording Available

 

Human Factors Engineering in New Product Development

webinar-speaker   Tom Kramer

webinar-time   120 Min

Product Id: 705153

This webinar will define human factors engineering and its role in the success of new product development. The session will use real world examples to demonstrate how human factors engineering makes a significant.

Recording Available

* Per Attendee $249

 

Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 704848

A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well. This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing cloud environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.

Recording Available

* Per Attendee $249

 

 

 

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